BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Modular Rail System

    Reg #: 3038503932 · FEI: 3038503932 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Smith & Nephew, Inc.
    Registration Number
    3038503932
    FEI Number
    3038503932
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Rd
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201253

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Software For Diagnosis/Treatment OSN
    Pin, Fixation, Threaded JDW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Modular Rail System ILIZAROV External Fixator JET-X Fixator TAYLOR SPATIAL FRAME External Fixator Other External Fixation

    Establishment Types

    Manufacture Medical Device